NCT04663555.

Study name	Effect of two different doses of dexamethasone in patients with ARDS and COVID‐19 (REMED)
Methods	Trial design: prospective, phase II, open‐label, RCT Sample size: 300 Setting: inpatient Language: Czech, English Number of centres: 11 Type of intervention (treatment/prevention): treatment
Participants	Inclusion criteria Adult (≥ 18 years of age) at time of enrolment Present COVID‐19 (infection confirmed by RT‐PCR or antigen testing) Intubation/mechanical ventilation or ongoing HFNC oxygen therapy Moderate or severe ARDS according to Berlin criteria: moderate ‐ PaO2/FiO2 100 to 200 mmHg; severe ‐ PaO2/FiO2 < 100 mmHg Admission to ICU in the last 24 h Exclusion criteria Known allergy/hypersensitivity to dexamethasone or excipients of the investigational medicinal product (e.g. parabens, benzyl alcohol) Fulfilled criteria for ARDS for ≥ 14 days at enrolment Pregnancy or breastfeeding Unwillingness to comply with contraception measurements from enrolment to at least 1 week after the last dose of dexamethasone (sexual abstinence is considered as adequate contraception method) End‐of‐life decision or patient is expected to die within next 24 h Decision not to intubate or ceilings of treatment in place Immunosuppression and/or immunosuppressive drugs in medical history: Systemic immunosuppressive drugs or chemotherapy in the past 30 days Systemic corticosteroid use before hospitalisation Any dose of dexamethasone during the present hospital stay for COVID‐19 for ≥ last 5 days before enrolment Systemic corticosteroids during present hospital stay for other conditions than COVID‐19 (e.g. septic shock) Present haematological or generalised solid malignancy Any of contraindications of corticosteroids, e.g. intractable hyperglycaemia; active gastrointestinal bleeding; adrenal gland disorders; a presence of superinfection diagnosed with locally established clinical and laboratory criteria without adequate antimicrobial treatment Cardiac arrest before ICU admission Participation in another interventional trial in the last 30 days
Interventions	Details of intervention Dose: dexamethasone 20 mg once daily on day 1 to 5, followed by dexamethasone 10 mg IV once daily on day 6 to 10 Route of administration: IV Treatment details of control group (e.g. dose, route of administration): dexamethasone 6 mg day 1 to 10 Concomitant therapy: no information
Outcomes	Primary outcome: number of ventilator‐free days at 28 days after randomisation, defined as being alive and free from mechanical ventilation (> 48 h)
Starting date
Contact information	Jan Maláska, MD, PhD, EDIC: +420723784101  Email: jan.malaska@gmail.com
Notes	Recruitment status: recruiting Prospective completion date: 31 March 2021 Date last update was posted: 4 February 2021 Sponsor/funding: Brno University Hospital